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Trial record 11 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

External Beam Radiotherapy for Muscle Invasive Bladder Cancer

This study is currently recruiting participants.
Verified April 2016 by Radiotherapie, University Hospital, Ghent
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748200
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Radiotherapie, University Hospital, Ghent
  Purpose
In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

Condition Intervention Phase
Toxicity Radiation: external beam radiotherapy (EBRT) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy

Resource links provided by NLM:


Further study details as provided by Radiotherapie, University Hospital, Ghent:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale [ Time Frame: 3 months after radiotherapy ]

Secondary Outcome Measures:
  • Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging [ Time Frame: 12 months after radiotherapy ]

Estimated Enrollment: 9
Study Start Date: March 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: external beam radiotherapy: Dose level 1
57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels
Experimental: external beam radiotherapy: dose level 2
60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels
Experimental: external beam radiotherapy: dose level 3
62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
Radiation: external beam radiotherapy (EBRT)
EBRT: 3 dose escalation levels

Detailed Description:

3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

  • Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.
  • Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy
  • Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (GTV) during external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy. In order to further improve the treatment accuracy, 5 planning Computed Tomographies and plans, with different bladder fillings will be made upfront in our study. During treatment the plan corresponding best with bladder filling at time of EBRT will be selected and delivered.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histological proven diagnosis of muscle invasive bladder cancer
  • stage <T3b tumours with pathological lymph nodes after extended pelvic lymph node dissection
  • World Health Organisation performance state 0-2
  • signed informed consent

Exclusion Criteria:

  • contra-indication for Diffusion-Weighted-Magnetic resonance imaging
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748200


Contacts
Contact: Valérie Fonteyne, MD, PhD valerie.fonteyne@uzgent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Valérie Fonteyne, MD PhD       valerie.fonteyne@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Valérie Fonteyne, MD; PhD University Hospital, Ghent
  More Information

Responsible Party: Radiotherapie, Radiation oncology and experimental cancer research, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02748200     History of Changes
Other Study ID Numbers: 2015/0169
First Submitted: March 18, 2015
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases